KAHLITY GmbH

The US FDA is actively shaping new regulations to enhance the safety and effectiveness of AI-enabled medical devices. As of October 2024, US FDA officials emphasized the importance of oversight, safety, and collaboration in AI-based healthcare, with ongoing evaluations of AI applications for clinical use. Looking ahead to 2025, the FDA's Center for Devices and Radiological Health (CDRH) plans to release critical guidance for AI in medical devices, addressing: 1. Lifecycle management, by establishing continuous monitoring protocols to maintain AI performance and safety. 2. Premarket submissions, by setting clear documentation and validation requirements for market approval. 3. Transparency and fairness, by ensuring AI tools are interpretable and unbiased for diverse patient populations. These efforts build on the FDA’s 2021 "AI/ML-Based SaMD Action Plan," designed for flexible AI regulation. With AI regulations evolving, KAHLITY is here to support organizations with compliance strategies tailored to these new FDA standards, guiding you from development to market readiness. https://lnkd.in/eW8UXk7Y #ArtificialIntelligence #AIinHealthcare #FDA #MedicalDeviceRegulation #KAHLITY

Issued in October 2024, the European Commission’s Q&A for Article 10a of MDR/IVDR addresses crucial updates for medical device manufacturers. The focus? Ensuring uninterrupted patient care by mandating proactive communication about supply disruptions. 💡 KAHLITY's support: Our team simplifies this compliance journey with tailored support; from risk assessments to stakeholder notifications. Stay compliant, and focus on what matters most: patient health. Reach out to learn how we can support your operations. Comment "Cheat Sheet" if you would like to receive our KAHLITY Cheat Sheet privately. #MedicalDevices #Compliance #KAHLITYGmbH #MDR #IVDR #PatientHealth

This article explores how manufacturers and consultants can overcome dependency cycles by fostering partnerships grounded in trust and respect, ultimately leading to more sustainable and impactful growth. #BusinessPartnerships #Consulting #TrustAndRespect #SustainableGrowth #KAHLITYValues #EmpowermentNotDependency

Some key insights from the latest Swiss Medtech Study 2024: The Swiss medtech industry is booming, creating 20 000 jobs in the last decade. As a Swiss Authorized Representative, KAHLITY GmbH helps clients meet regulatory requirements while supporting innovation. With the FDA becoming a preferred certification route over EU-MDR, KAHLITY ensures clients are prepared for international market entry, especially in the US. The digital transformation is reshaping medtech, and AI drives innovation across the industry. KAHLITY is leveraging these advancements to help clients stay ahead. For more details: https://lnkd.in/ex6g6fk6 #Medtech #SwissInnovation #CHREP #FDA #AIinHealthcare #KAHLITYGmbH

Swissmedic has launched Swissdamed, a comprehensive new database for the registration of economic operators and medical devices in Switzerland. This platform enhances transparency and makes crucial information easily accessible to both the public and healthcare professionals. Swissdamed is being rolled out in phases, starting with the "Actors" module, which is already live. KAHLITY GmbH, an ISO 13485 certified company, serves as an Authorized Representative and Importer economic operator under this new system. For more details, learn more about KAHLITY GmbH here:

Hello everyone, We are thrilled to share some fantastic news! Our entities, KAHLITY GmbH and KAHLITY France SAS, have just achieved ISO 13485 certification. This certification covers our roles as a Swiss and European Authorized Representative, Importer, and provider of Consulting services to companies in the medical devices and pharmaceutical industries. We are especially proud to announce that we received zero findings during the certification process, underscoring our commitment to excellence and regulatory compliance. Please see the certificate below. For more information, feel free to reach out to us at info@kahlity.com. Best regards, The KAHLITY Team

Hello everyone, We are thrilled to share some fantastic news! Our entities, KAHLITY GmbH and KAHLITY France SAS, have just achieved ISO 13485 certification. This certification covers our roles as a Swiss and European Authorized Representative, Importer, and provider of Consulting services to companies in the medical devices and pharmaceutical industries. We are especially proud to announce that we received zero findings during the certification process, underscoring our commitment to excellence and regulatory compliance. Please see the certificate below. For more information, feel free to reach out to us at info@kahlity.com. Best regards, The KAHLITY Team

The first module of the swissdamed medical devices database, the Actors module, will go live on 6 August 2024, changing the current registration process for Swiss economic operators. Existing operators with a CHRN will have their data migrated and need only to verify their information. KAHLITY GmbH is here to assist with authorized representative services. https://lnkd.in/eUjAGcCa

https://lnkd.in/eMqc2Vwa The new European guidance for Category C interventional performance studies of IVDs, MDCG 2024-4, is now available. This includes an Excel form for reporting serious adverse events and device deficiencies. These guidelines, including the MDCG 2024-4 Appendix, should also be used for reports in Switzerland. For additional information on reporting duties, please refer to the Swissmedic information sheet BW600_00_016e_MB.

The launch of the Swissdamed "going-live" date has been postponed to the second half of 2024. Swissdamed, which stands for the Swiss Database on Medical Devices, is an IT system managed by Swissmedic. It facilitates compliance with Swiss regulations regarding medical devices and in vitro diagnostic medical devices. The system comprises two interconnected modules accessible only to registered users, along with a freely accessible search function. These modules are being rolled out gradually: 1. Registration of companies and economic operators (ACT module) - scheduled for release in the second half of 2024. 2. Swissdamed as a freely accessible platform - also scheduled for release in the second half of 2024. 3. Registration of devices (UDI module) - will be available as a minimal viable product (MVP) four months after the ACT module goes live. Further information here: https://lnkd.in/gSBi_hGG